BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETURN

    MDR report key: 8048094 · Received November 7, 2018

    Report

    Report Number
    3009481053-2018-00045
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    September 29, 2018
    Report Date
    November 7, 2018
    Manufacturer
    HANDICARE AB
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WING HANDLES NEAR DEVICE BASE PLATE DETACH FROM DEVICE DURING PATIENT TRANSFER FROM WHEELCHAIR TO CHAIR. THE PATIENT DID NOT SUSTAIN ANY INJURY FROM THE EVENT. THE DEVICE WAS OPERATED BY LAY USER IN THE PATIENT'S HOME. THE DEVICE WAS QUARANTINED AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887317 RETURN TRANSFER AID IKX HANDICARE AB 7500

    Patients

    Seq Age Sex Outcome Treatment
    1